Soni B K, Langan J P
MycoTechnology, Inc., 3155 N Chambers Rd, Suite E, Aurora, CO, 80011, United States.
Toxicol Rep. 2018 Jan 12;5:196-206. doi: 10.1016/j.toxrep.2017.12.015. eCollection 2018.
The present study investigates whether ClearTaste is mutagenic/genotoxic by employing it as a test article in bacterial reverse mutation (Ames test) and in vitro human peripheral blood lymphocyte micronucleus assays conducted by a Good Laboratory Practice certified third party as parameterized by the United States Food and Drug Administration. ClearTaste is a taste modulator derived from the filtrate of submerged Cordyceps sinensis and is typically processed into a powder. It functions as a bitter, sour, astringency, metallic and lingering aftertaste mitigator/blocker. The Ames test includes revertant colony counts almost exclusively less than 100/plate and significantly fewer ClearTaste counts as opposed to known mutagen counts. The micronucleus assay reported cytotoxicity exclusively < 25% for doses up to 2,000 μg/L with Cytokinesis Block Proliferation Indices less than water and statistically significant differences between micronucelated cells post dosing compared to cyclophosphamide and vinblastine controls. The conclusion of these data is that ClearTaste is neither muta- nor carcinogenic.
本研究通过将ClearTaste作为受试物,在美国食品药品监督管理局参数化的、由一家具有良好实验室规范资质的第三方进行的细菌回复突变试验(艾姆斯试验)和体外人外周血淋巴细胞微核试验中,研究其是否具有致突变性/遗传毒性。ClearTaste是一种从深层发酵的冬虫夏草滤液中提取的味觉调节剂,通常加工成粉末。它可减轻/阻断苦味、酸味、涩味、金属味和余味。艾姆斯试验中回复菌落数几乎均小于100/平板,与已知诱变剂计数相比,ClearTaste计数显著更少。微核试验报告称,剂量高达2000μg/L时,细胞毒性仅<25%,胞质分裂阻滞增殖指数低于水,给药后微核细胞与环磷酰胺和长春碱对照组相比有统计学显著差异。这些数据的结论是,ClearTaste既无致突变性也无致癌性。